Senior Statistical Programmer II, Early Oncology

Company: AstraZeneca
Location: Berkeley
Posted on: August 5, 2022

Job Description:

Senior Statistical Programmer II - Early Oncology Play a critical role in making our pipeline accessible to patients. Do you have expertise in, and passion for, Programming? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process. Main Duties and Responsibilities Depending on your previous experience and education, you will use and develop your programmer know-how in a data driven environment. You may already be equipped to lead programmer employees, either by technical leadership or line management. We offer a role suited for your competence. Your responsibilities will include: Statistical programming deliverables for regulatory submissions, including specification and delivery of coordinated databases, outputs and response to regulatory questions; commercialisation and reimbursements Delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB) Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams Development of standard methodology to improve quality, efficiency and effectiveness Essential Requirements You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual. You have a bachelors degree in Mathematics, Computer Science, Statistics, Life Sciences or similar area You have advanced SAS Programming and CDISC standards knowledge You possess excellent interpersonal skills. 4 years of relevant experience. This role can sit at our Gaithersburg, MD; Wilmington DE; South San Francisco, CA; or Waltham, MA location Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare. So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available and we hope it's yours. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedI Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Keywords: AstraZeneca, Berkeley , Senior Statistical Programmer II, Early Oncology, IT / Software / Systems , Berkeley, California